Allogene Therapeutics Receives FDA Orphan Drug Designation (ODD) for ALLO-715 for the Treatment of Multiple Myeloma (MM)

  • ODD Follows RMAT Designation Granted to ALLO-715 by the U.S. Food and Drug Administration in Multiple Myeloma Patients
  • Phase 1 Data from the ALLO-715 UNIVERSAL Trial Demonstrated for the First Time that an Allogeneic CAR T Therapy Directed at BCMA Can Achieve Clinical Responses While Eliminating the Need for Bridging Therapy or Delays in Treatment Associated with Manufacturing
  • Next Clinical Update from the ALLO-715 UNIVERSAL Trial Planned for Late 2021

SOUTH SAN FRANCISCO, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to ALLO-715 for the treatment of multiple myeloma.

Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma were presented at an oral session of the American Society of Hematology annual meeting in December 2020. In April 2021, ALLO-715 was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA). The UNIVERSAL trial continues to enroll patients to ALLO-715 including in combination with nirogacestat, a gamma secretase inhibitor from SpringWorks Therapeutics and in consolidation therapy.

“We are pleased to have received ODD for ALLO-715 just months after the FDA granted RMAT designation. These designations from the FDA underscore the importance of bringing this important therapeutic option to patients with multiple myeloma,” said Rafael Amado, M.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. “We look forward to presenting the next update from our UNIVERSAL trial by the end of 2021 and providing additional insight into the potential of our allogeneic cell therapy platform.”

Orphan-drug designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the U.S. ODD granted therapies entitle companies to development incentives including tax credits for clinical testing, prescription drug user fee exemptions, and seven year marketing exclusivity in the event of regulatory approval. ODD does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

About ALLO-715

ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies. Multiple myeloma originates in the bone marrow, and it is characterized by abnormalities in plasma cells that reproduce uncontrollably in the bone marrow and other disease sites. Multiple myeloma is incurable for most patients, as relapses occur despite most treatments available. Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma were presented in December 2020 at an oral session of the American Society of Hematology (ASH) annual meeting. In April 2021, ALLO-715 was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA).

About Allogene Therapeutics

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to progress the UNIVERSAL trial and present any data from the trial; clinical outcomes, which may materially change as patient enrollment continues and more patient data become available; and the potential benefits of AlloCAR T™ therapy. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the SEC, including without limitation in its Form 10-Q for the quarter ended June 30, 2021. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.

ALLO-715 utilizes TALEN® gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at BCMA and holds all global development and commercial rights for this investigational candidate.

Allogene Media/Investor Contact:

Christine Cassiano
Chief Communications Officer
(714) 552-0326
[email protected]



AgEagle Aerial Systems Announces the Dismissal of Consolidated Securities Class Action Lawsuit and Related Derivative Lawsuits

WICHITA, Kan., Aug. 12, 2021 (GLOBE NEWSWIRE) — AgEagle Aerial Systems Inc. (NYSE American: UAVS) (“AgEagle” or the “Company”), an industry-leading drone solutions provider, today announced that multiple, previously-disclosed lawsuits against the Company and certain of its current and former officers and directors have been dismissed.

As previously disclosed in the Company’s SEC filings, AgEagle and certain of its current and former officers and directors were named as defendants in two putative securities class actions filed in the U.S. District Court for the Central District of California (Lopez v. AgEagle Aerial Systems Inc., et al., Case No. 2:21-cv01810; and Madrid v. AgEagle Aerial Systems Inc., et al., Case No. 2:21-cv-01991). These matters were consolidated, and a Lead Plaintiff designated by Court Order. The Company is now pleased to report that on July 30, 2021, the Lead Plaintiff filed a voluntary dismissal of the consolidated securities class action.

Separately, two shareholders filed a derivative compliant on behalf of the Company and against certain of our current and former officers and directors before the Nevada federal court [Nostrand and Rickerson v. Mooney et al. (Defendants) and AgEagle Aerial Systems Inc., (Nominal Defendant), Case No. 3:21-cv-00130.]. AgEagle is pleased to report that on July 20, 2021, the Plaintiffs in this Nevada derivative action filed a voluntary dismissal of the action, and the court designated the case “closed” and “terminated.”

Finally, on July 27, 2021, a separate shareholder filed a similar derivative complaint on behalf of the Company and against certain of its current and former officers and directors in the U.S. District Court for the Central District of California (Granja v. AgEagle Aerial Systems Inc., et al, Case No. 2:21-cv-06056). AgEagle is pleased to report that on August 11, 2021, the Plaintiff in this California derivative action filed a voluntary dismissal of the action.

These dismissals resolve all known litigation against the Company and its officers and directors concerning Company operations.

About AgEagle Aerial Systems Inc.

Founded in 2010, AgEagle is one of the nation’s leading commercial drone technology providers. AgEagle’s mission is to empower The Drone Age by providing American-made drone solutions to the world. The Company is leveraging its reputation as one of the industry’s premium technology solutions and aerial data intelligence providers to deliver high performance, end-to-end drone solutions for commercial use worldwide. AgEagle products are proudly manufactured and assembled in the United States. For additional information, please visit our websites at www.ageagle.com, www.measure.com and www.micasense.com.


Forward-Looking Statements


This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management’s current expectations include those risks and uncertainties relating to our competitive position, the industry environment, potential growth opportunities, and the effects of regulation and events outside of our control, such as natural disasters, wars or health epidemics. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

AgEagle Aerial Systems Contacts:

Investor Relations:

Gateway Investor Relations
Matt Glover or Cody Cree
Phone: 949-574-3860
Email: [email protected]
           Media:

Clarity PR
Monica Feig
Phone: 818-917-0770
Email: [email protected]
     



abercrombie kids Renews “Kind Crew” Digital Series for Second Season

Season 2 of the popular digital series will discuss anxiety about going back to school and more, available now on Nickelodeon’s YouTube channel

NEW ALBANY, Ohio, Aug. 12, 2021 (GLOBE NEWSWIRE) — abercrombie kids, a brand in the Abercrombie & Fitch Co. (NYSE: ANF) portfolio, has renewed its popular “Kind Crew” digital series for a second season, which is available now exclusively on Nickelodeon’s YouTube channel. The series continues to help inspire young people to make the world a more compassionate, understanding and kind place. It will feature a new cast of four phenomenal kids as well as special guests who can speak to important topics at hand – such as returning to school, how to leverage your uniqueness as your “superpower” and more.

Created in partnership with Nickelodeon and produced by Velocity, ViacomCBS’s branded content studio, the second season of the Kind Crew builds on its popular first season, which encouraged healthy conversations on topics such as addressing racism and the importance of voting. This year’s season aims to continue to support kids and empower them to discuss their feelings during times of change.

“We’re so proud to bring the Kind Crew back for a second season, and to continue to provide a space for kids and their families to discuss topics that impact kids’ daily lives,” said Carey Krug, SVP of Marketing at Abercrombie & Fitch. “We have all had to learn how to navigate this new ‘normal,’ which for kids, means returning to school while feeling a mix of joy and anxiety, particularly for those who were not physically in school last year. We hope the second season of the Kind Crew inspires kids to both share their feelings and support one another as we head back to school this year.”

In addition to appearing on the YouTube series, throughout the season, the new Kind Crew cast will engage with fellow kids via social media posts on their own channels and the abercrombie kids’ brand accounts. This year’s Kind Crew cast is made up of four kids who are nothing short of awesome: Keedron Bryant (@keedronbryant), Ava Clarke (@theavaclarke), Merrick Hanna (@merrickhanna) and Pressley Hosbach (@pressleyhosbach).

To meet the new Kind Crew cast and hear what they have to say about going back to school plus their own superpowers, watch the first two episodes of season 2 on Nickelodeon’s Youtube channel. And to keep up with all the kindness, make sure to follow abercrombie kids’ on Instagram at @abercrombiekids.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

A&F cautions that any forward-looking statements (as such term is defined in the Private Securities Litigation Reform Act of 1995) contained herein or made by management or spokespeople of A&F involve risks and uncertainties, and are subject to change based on various important factors, many of which may be beyond the Company’s control. Words such as “estimate,” “project,” “plan,” “believe,” “expect,” “anticipate,” “intend,” and similar expressions may identify forward-looking statements. Except as may be required by applicable law, we assume no obligation to publicly update or revise our forward-looking statements. Risks and uncertainties related to the duration and impact of the COVID-19 pandemic on the Company and the factors disclosed in “ITEM 1A. RISK FACTORS” of A&F’s Annual Report on Form 10-K for the fiscal year ended January 30, 2021 and in A&F’s subsequently filed quarterly reports on Form 10-Q, in some cases have affected, and in the future could affect, the company’s financial performance and could cause actual results for fiscal 2021 and beyond to differ materially from those expressed or implied in any of the forward-looking statements included in this press release or otherwise made by management. 

ABOUT ABERCROMBIE KIDS
 

A global specialty retailer of quality, comfortable, made-to-play favorites, abercrombie kids sees the world through kids’ eyes, where play is life and every day is an opportunity to be anything and better everything. 

abercrombie kids is a brand in the Abercrombie & Fitch Co. (NYSE: ANF) portfolio and is sold through more than 230 stores worldwide (includes Abercrombie & Fitch) and www.abercrombiekids.com globally. 

Media Contact:

Cory Weaver, Ph.D.
Abercrombie & Fitch
(614) 586-2717
[email protected] 

Business Media Contact:

Kara Page
Abercrombie & Fitch Co.
(614) 283-6192
[email protected]

Investor Contact:

Pam Quintiliano
Abercrombie & Fitch Co.
(614) 283-6877
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f4d2729a-c156-444f-9f02-51428abe1731



Ciena Announces Reporting Date and Web Broadcast for Fiscal Third Quarter 2021 Results

Ciena Announces Reporting Date and Web Broadcast for Fiscal Third Quarter 2021 Results

HANOVER, Md.–(BUSINESS WIRE)–Ciena® Corporation (NYSE: CIEN) expects to announce its fiscal third quarter financial results on Thursday, September 2, 2021 before the open of the financial markets. The press release will be available on Ciena’s website at www.ciena.com.

In conjunction with the announcement, Ciena will post an additional set of supporting materials to the Quarterly Results page of the Investor Relations section of its website. Ciena’s management will then host a live audio web broadcast beginning at 8:30 a.m. Eastern accessible via www.ciena.com.

Rebroadcast Information

For those listeners unable to participate in the live web broadcast, an archived version of the conference call will be available shortly following the conclusion of the live call in the Events & Presentations section of the Investor Relations section of Ciena’s website.

About Ciena

Ciena (NYSE: CIEN) is a networking systems, services and software company. We provide solutions that help our customers create the Adaptive Network™ in response to the constantly changing demands of their users. By delivering best-in-class networking technology through high-touch consultative relationships, we build the world’s most agile networks with automation, openness and scale. For updates on Ciena, follow us on Twitter @Ciena, LinkedIn, the Ciena Insights blog, or visit www.ciena.com.

Press:

Jamie Moody

Ciena Corporation

+1 (214) 995-8035

[email protected]

Investor:

Gregg Lampf

Ciena Corporation

+1 (410) 694-5700

[email protected]

KEYWORDS: United States North America Maryland

INDUSTRY KEYWORDS: Software Networks Internet Data Management Technology VoIP Mobile/Wireless Security

MEDIA:

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BOSS Revolution Money Transfer Accelerates Network Expansion through Partnership with TerraPay

Launches TerraPay powered transfers to Senegal
and Benin

Newark, NJ, Aug. 12, 2021 (GLOBE NEWSWIRE) —

BOSS Revolution Money Transfer,
the international remittance service of IDT Corporation (NYSE: IDT), today announced a partnership with TerraPay, a global payments infrastructure company, to provide BOSS Revolution customers with new money transfer destinations across Africa, Asia, LATAM and Europe.

BOSS Revolution has begun offering seamless and secure payments to mobile wallets in Senegal and Benin through TerraPay to begin the expansion.

“Our customers in the US can now send money to friends and family in Senegal, Benin and 36 other countries including over 309,000 points of payment,” said Alfredo O’Hagan, IDT’s SVP for Consumer Payments. “We are delighted to partner with TerraPay as we open new corridors and emphasize real-time payment options leveraging their extensive platform.”

The BOSS Revolution Money Transfer service is readily available through the convenient BOSS Revolution Money app and its nationwide network of BOSS Revolution Money Transfer retailers. First time users of the app (free at App Store and Google Play) pay no fees on any transfer up to $300. BOSS Revolution Money Transfer is also available online or at any BOSS Revolution Money retailer.

As a B2B company, TerraPay connects multiple and diverse payment instruments and payment modes, with a single API integration – 4 Bn+ bank accounts, 500 Mn+ mobile wallets, and a large and diversified merchant ecosystem spanning across 79 receive countries and 153 send countries. With international remittances at the core, the company is embarking on creating unified payment rails for businesses and merchants across the globe. TerraPay’s endeavor is to strengthen and offer value-added services on its digital global payments highway, deepening engagement and adding more participants to a cohesive financial ecosystem.

Commenting on the relationship, Ani Sane, Co-founder and Chief Business Officer, TerraPay, said, “Our exciting partnership with BOSS Revolution will empower customers in the US to connect with family and friends worldwide, starting with mobile wallets in Senegal and Benin, while growing both companies’ footprints. This collaboration is another example of the impact our digital interoperable payment network provides across regions. We are driving greater access to financial services globally for all our partners and customers.”


About IDT Corporation:


IDT Corporation
(NYSE: IDT) is a global provider of fintech, cloud communications and traditional communications services. We make it easier for families to connect, support and share across international borders. We also enable businesses to transact and communicate with their customers with enhanced intelligence and insight.

Our BOSS Revolution branded money transfer and international calling services make sending money and speaking with friends and family around the world convenient and reliable. National Retail Solutions’ (NRS) point-of-sale retail network enables independent retailers to operate and process transactions more effectively while providing advertisers and consumer marketers with unprecedented reach into underserved consumer markets. net2phone’s unified communications as a service solution provides businesses with intelligently integrated cloud communications and collaboration solutions across channels and devices. Our IDT Carrier Services and IDT Express wholesale offerings enable communications companies to provision and manage international voice and SMS services.


About TerraPay:

TerraPay is a licensed digital payments infrastructure and solutions provider, paving the global payments highway. The company’s robust foundation and innovative platform technology serve as the digital interoperability engine enabling customers and businesses globally to send and receive payments on a secure, transparent, efficient, and real-time basis. The agile network supports diverse payment instruments and types of payments while adhering to complex regulations and compliance standards in different markets. For more information, please visit terrapay.com


Contact

:

Bill Ulrey
IDT Investor Relations
Phone: (973) 438-3838
E-mail: [email protected]



MIMEDX Promotes Marion Snyder to Chief of Staff, Senior Vice President, Government Affairs

Promotion Recognizes Skilled Leadership and Contributions to MIMEDX’s Continued Growth

MARIETTA, Ga., Aug. 12, 2021 (GLOBE NEWSWIRE) — MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, today announced the promotion of Marion Snyder to Chief of Staff, Senior Vice President, Government Affairs. As a member of the Senior Leadership Team, Ms. Snyder will oversee strategic projects requiring cross-functional input, and drive the integration, effectiveness, and efficiency of decision making throughout the organization to advance multiple, company-wide initiatives. She will continue in her role as co-chair of the Company’s Inclusion and Diversity Council and serve as an important voice for MIMEDX’s government affairs and patient advocacy efforts. As a policy contributor and trusted advisor, she will serve as a significant communications link with the broader organization as a whole. With this promotion, the Company has commenced an executive search to fill Ms. Snyder’s prior role of Senior Vice President, Market Access.

Timothy R. Wright, MIMEDX Chief Executive Officer, said, “As leaders, we have an opportunity each day to make a difference for patients. I am confident that Marion’s experience, character, and leadership will help us continue our forward momentum to best meet the needs of our employees, customers, and patients. Our ability to deliver innovation that matters, focus on operational excellence, and hold ourselves accountable to each other enables all to achieve more.”

Ms. Snyder commented, “I look forward to working alongside Tim Wright and the MIMEDX leadership team on initiatives that increase patient access to evidence-based, regenerative technologies and elevate the standard of care. MIMEDX is a different company today, having accomplished a number of critical milestones that reflect sound business practices and an ethical culture, and position us for the future. I am excited to be a part of this incredible team at this time in MIMEDX’s history as we further our pipeline through innovation, elevate patient awareness about disease symptoms, and educate key stakeholders on the potential for our differentiated solutions to reduce cost to the healthcare system and restore quality of life.”

Ms. Snyder joined MIMEDX in 2013, and throughout her eight-year tenure she has continued to take on roles of increasing responsibility, most recently serving as Senior Vice President, Market Access. Her instincts and experience with customer contracting and reimbursement strategies, and overall market acumen have provided valuable expertise and leadership to advance a number of Company initiatives, and her reputation for cross-functional leadership is well appreciated.

Prior to joining MIMEDX, Ms. Snyder spent 13 years with Pfizer in a variety of roles, including Director of Payer Marketing for Enbrel, and started her career in sales and sales management with Johnson & Johnson. She earned her Bachelor of Science degree in Business Administration with a concentration in Marketing at Delaware Valley University.

About MIMEDX

MIMEDX is an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare. As a pioneer in placental biologics, we have both a base business, focused on addressing the needs of patients with acute and chronic non-healing wounds, and a promising late-stage pipeline targeted at decreasing pain and improving function for patients with degenerative musculoskeletal conditions. We derive our products from human placental tissues and process these tissues using our proprietary methods, including the PURION® process. We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts. MIMEDX has supplied over two million allografts, through both direct and consignment shipments. For additional information, please visit www.mimedx.com.

Contacts

Investors:

Jack Howarth
Investor Relations
404.360.5681
[email protected] 

Media:

Hilary Dixon
Corporate & Strategic Communications
770.651.9307
[email protected] 



PhaseBio Reports Second-Quarter 2021 Financial Results and Recent Business Highlights

PhaseBio Reports Second-Quarter 2021 Financial Results and Recent Business Highlights

Entered exclusive licensing agreement with Alfasigma S.p.A with up to $245 million in milestone payments and tiered royalty payments for development and commercialization of bentracimab in European and other key markets

Achieved interim enrollment milestone with first 143 bentracimab patients enrolled in the REVERSE-IT pivotal Phase 3 trial, with top-line results from interim analysis expected later this year

Bentracimab Phase 2b trial enrollment completed; safety and efficacy data will supplement Phase 3 interim results, with combined data package planned to serve as the basis for a Biologics License Application (BLA) submission in mid-2022

Cash and Equivalents of $64.5 million as of June 30, 2021

MALVERN, Pa. & SAN DIEGO–(BUSINESS WIRE)–PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today provided an update on corporate activities and reported second-quarter 2021 financial results.

“Since the end of the first quarter, the PhaseBio team has made excellent progress with our lead program, bentracimab, including completing enrollment of the first 143 patients in our pivotal Phase 3 REVERSE-IT trial, completing enrollment in the Phase 2b bentracimab trial and signing an exclusive licensing agreement with Alfasigma S.p.A for commercialization in nearly 50 countries across Europe and the Commonwealth of Independent States,” said Jonathan P. Mow, Chief Executive Officer, PhaseBio Pharmaceuticals. “We believe these clinical and strategic milestones position PhaseBio to finish 2021 with significant momentum. The bentracimab program remains on track, and with Alfasigma taking the commercial lead across Europe and other key markets, we believe PhaseBio is well positioned to focus on the BLA submission for bentracimab and prepare for expected commercial launch in the United States.”

Program Highlights and Corporate Updates

  • Achieved Enrollment Milestones Supporting Interim Analysis of REVERSE-IT Global Phase 3 Trial of Bentracimab for Reversal of Antiplatelet Effects of Ticagrelor: In August 2021, PhaseBio announced that it had completed enrollment of the first 143 patients in its pivotal Phase 3 REVERSE-IT trial for its lead product candidate bentracimab, 138 of whom required urgent surgery or an invasive procedure and five of whom experienced uncontrolled major or life-threatening bleeding. In total, the REVERSE-IT trial is expected to enroll approximately 200 major bleeding or urgent surgery patients at sites in the United States, Canada, European Union and China. Based on prior guidance following the End of Phase 1 Meeting with the U.S. Food and Drug Administration (FDA) to balance the two patient populations, the REVERSE-IT trial does not allow enrollment of more than approximately two thirds of either the uncontrolled major or life-threatening bleeding population or urgent surgery or invasive procedure population. Because the total number of patients enrolled to date includes 138 patients who required urgent surgery or an invasive procedure, the surgery cohort of the trial has been fully enrolled. With the successful completion of enrollment in this surgery cohort, REVERSE-IT trial sites have shifted focus to enrolling patients with uncontrolled major or life-threatening bleeding events. The Company is continuing to attempt to accelerate enrollment of patients with uncontrolled major or life-threatening bleeding, including by working to increase the number of enrolling clinical trial sites in the United States, Canada and the European Union, as it believes that a broader site footprint will increase the probability of enrolling these patients. The FDA also previously indicated that an interim analysis of the first approximately 100 patients enrolled in the REVERSE-IT trial would be sufficient to support the submission of a BLA for accelerated approval. The FDA recommended that the 100 patients comprising the interim analysis include approximately 50 patients from each of the uncontrolled major or life-threatening bleeding population and the urgent surgery or invasive procedure population, although the FDA noted that whether there are an adequate number of patients from either cohort would be a review issue and considered in the context of other data submitted with the BLA. The Company is commencing preparation of the BLA and targeting a BLA submission to the FDA in mid-2022.
  • Completed Enrollment in Bentracimab Phase 2b trial: In August 2021, PhaseBio announced the completion of enrollment in the randomized, double-blind, placebo-controlled Phase 2b trial of bentracimab. The Phase 2b trial enrolled 200 healthy older and elderly (ages 50 to 80) subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin; 150 subjects were randomized to receive bentracimab, with reversal of the antiplatelet effects of ticagrelor, as measured by the VerifyNow® PRUTest biomarker, serving as the primary endpoint for the trial. Top-line results from the Phase 2b trial are expected later this year. The Phase 2b trial was designed to supplement the safety and efficacy results that will be included in the BLA submission.
  • Announced Approval of Bentracimab IND in China: In August 2021, PhaseBio announced that the Investigational New Drug (IND) application for bentracimab submitted to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) in collaboration with development partner, SFJ Pharmaceuticals (SFJ), has been approved. PhaseBio and SFJ anticipate enrolling the first patients at sites in China later in 2021. Patients enrolled in China are expected to contribute to the completion of full enrollment of the trial, post interim analysis. In January 2020, PhaseBio announced a financing and co-development partnership with SFJ Pharmaceuticals, and since this time, SFJ has been leading clinical development efforts in China. PhaseBio retains commercial rights to bentracimab in China and is pursuing prospective commercial partners to license the marketing rights in China and other countries in the Asia-Pacific region.
  • Entered European Licensing Agreement with Alfasigma for Commercialization of Bentracimab: In June 2021, PhaseBio announced an exclusive licensing agreement with Alfasigma, a privately owned specialty pharmaceutical company focused on commercializing medicines in Europe and other key markets, for the commercialization of bentracimab. Under the terms of the license agreement, PhaseBio received a $20 million upfront payment and will be eligible to receive up to $35 million in pre-revenue regulatory milestones and up to $190 million in payments contingent upon the achievement of certain sales milestones. PhaseBio will also receive tiered royalties on net sales, with percentages starting in the low double digits and escalating up to the mid-twenties.
  • Presented Real-World Healthcare Cost and Bleeding Cost Data Featured at the International Society for Pharmacoeconomic and Outcomes Research (ISPOR) Virtual 2021 Conference: In May 2021, PhaseBio presented a poster analysis of the IBM® MarketScan® Commercial and Medicare Supplemental claims databases and focused on patients newly initiating a P2Y12 inhibitor, factor Xa inhibitor or dabigatran between 2014 and 2018. Among other things, results of the analyses demonstrated that, in the year prior to initiating therapy, total healthcare costs were higher among P2Y12 inhibitor patients compared to factor Xa and dabigatran patients. These conference proceedings present compelling evidence of an unmet medical and pharmacoeconomic need for an effective reversal agent for patients treated with P2Y12 inhibitors.
  • Presented Real-World Bleeding and Surgery Data Featured at The American College of Cardiology’s 70th Annual Scientific Session: In May 2021, PhaseBio presented a poster summarizing an analysis of the IBM® MarketScan® Commercial and Medicare Supplemental claims databases and focused on patients newly initiating a P2Y12 inhibitor, factor Xa inhibitor or dabigatran between 2014 and 2018. The results of the analysis demonstrated that patients receiving P2Y12 inhibitors presented a significantly higher burden of baseline comorbid conditions than factor Xa and dabigatran patients. Additionally, the results indicate that bleeding complications and medical procedures are common in patients taking antithrombotic medications. PhaseBio and the authors believe this study demonstrates an unmet need for an effective reversal agent for patients prescribed P2Y12 inhibitors.
  • SFJ Financing and Co-Development Agreement Update: From execution of the co-development agreement through June 30, 2021, SFJ has funded or reimbursed $77.5 million of clinical trial costs and other expenses of the initial $90.0 million commitment under the agreement, leaving $12.5 million of funding remaining available to support the bentracimab Phase 3 program. PhaseBio is eligible to receive up to an additional $30 million of funding if specific, pre-defined clinical development milestones for bentracimab are met.

Second-Quarter 2021 Financial Results

  • Cash and cash equivalents at June 30, 2021 were $64.5 million, compared to $28.1 million at December 31, 2020. The increase reflects proceeds from the March 2021 offering of common stock, partially offset by cash used in operating activities.
  • Sublicense revenue for the quarter was $10.3 million and reflects recognition of a portion of the upfront milestone payment received as part of the Alfasigma licensing agreement.
  • Net loss for the quarters ended June 30, 2021 and 2020 was $28.7 million.
  • Research and development expense increased to $27.4 million for the quarter ended June 30, 2021, as compared to $20.9 million for the same period in 2020, driven by an increase in manufacturing, clinical and nonclinical development activities related to bentracimab.
  • General and administrative expense increased to $4.0 million for the quarter ended June 30, 2021, compared to $3.2 million for the same period in 2020.

About PhaseBio

PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. The company’s pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly vasoactive intestinal peptide (VIP) receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio’s proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including pemziviptadil, and drives both internal and partnership drug-development opportunities.

PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit www.phasebio.com, and follow us on Twitter @PhaseBio and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “potential,” “projects,” “target,” “will,” “would” and “future” or similar expressions are intended to identify forward-looking statements.

Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and our research, development and regulatory plans for our product candidates, the timing of availability or disclosure of data from those clinical trials and the timing of planned regulatory submissions, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed, including through our partnerships with Alfasigma and SFJ. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law.

PhaseBio Pharmaceuticals, Inc.

Condensed Balance Sheets

(in thousands)

(unaudited)

 

June 30,

 

December 31,

 

2021

 

2020

Assets:

   

Cash and cash equivalents

 

$

64,456

 

 

$

28,122

 

Receivable from sublicense

 

 

18,400

 

 

 

 

Prepaid expenses and other current assets

 

 

5,644

 

 

 

12,027

 

Property and equipment, net

 

 

10,379

 

 

 

8,224

 

Operating lease right-of-use assets

 

 

1,701

 

 

 

1,927

 

Other non-current assets

 

 

57

 

 

 

57

 

Total assets

 

$

100,637

 

 

$

50,357

 

     

Liabilities and stockholders’ deficit:

   

Current portion of long-term debt

 

$

5,384

 

 

$

5,355

 

Current portion of deferred sublicense revenue

 

 

1,424

 

 

 

 

Accounts payable, accrued expenses and other current liabilities

 

 

9,366

 

 

 

9,605

 

Long-term debt, net

 

 

4,073

 

 

 

6,773

 

Operating lease liabilities, net

 

 

1,306

 

 

 

1,548

 

Deferred sublicense revenue, net

 

 

8,238

 

 

 

 

Development derivative liability

 

 

89,329

 

 

 

51,719

 

Other long-term liabilities

 

 

692

 

 

 

559

 

Stockholders’ deficit

 

 

(19,175

)

 

 

(25,202

)

Total liabilities and stockholders’ deficit

 

$

100,637

 

 

$

50,357

 

PhaseBio Pharmaceuticals, Inc.

Condensed Statements of Operations

(in thousands, except share and per share amounts)

(unaudited)

Three Months Ended June 30,

Six Months Ended June 30,

2021

2020

2021

2020

 

Revenue:

Sublicense revenue

$

10,337

 

$

 

$

10,337

 

$

 

Grant revenue

 

 

 

 

 

 

 

320

 

Total revenue

 

10,337

 

 

 

 

10,337

 

 

320

 

Operating expenses:

Research and development

 

27,366

 

 

20,856

 

 

49,686

 

 

32,305

 

General and administrative

 

4,024

 

 

3,242

 

 

7,351

 

 

6,401

 

Total operating expenses

 

31,390

 

 

24,098

 

 

57,037

 

 

38,706

 

Loss from operations

 

(21,053

)

 

(24,098

)

 

(46,700

)

 

(38,386

)

Other (expense) income

 

(6,026

)

 

(4,044

)

 

(7,737

)

 

(4,661

)

Net loss before income taxes

 

(27,079

)

 

(28,142

)

 

(54,437

)

 

(43,047

)

Provision for income taxes

 

1,600

 

 

 

 

1,600

 

 

 

Net loss

$

(28,679

)

$

(28,142

)

$

(56,037

)

$

(43,047

)

 

Net loss per common share, basic and diluted

$

(0.60

)

$

(0.98

)

$

(1.41

)

$

(1.50

)

 

Weighted average common shares outstanding, basic and diluted

 

47,985,871

 

 

28,805,238

 

 

39,680,408

 

 

28,789,256

 

 

Investor Contact:

John Sharp

PhaseBio Pharmaceuticals, Inc.

Chief Financial Officer

(610) 981-6506

[email protected]

Media Contact:

Will Zasadny

Canale Communications, Inc.

(619) 961-8848

[email protected]

KEYWORDS: United States North America California Pennsylvania

INDUSTRY KEYWORDS: Health Clinical Trials Research Science Pharmaceutical Cardiology Biotechnology

MEDIA:

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Kaizen Approach Transforms Security With Citrix® Secure Access Solutions

Kaizen Approach Transforms Security With Citrix® Secure Access Solutions

Firm leverages cloud offerings to secure applications and data without hindering employee experience

FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–
Applications, data and people are the most valued assets of any organization and must be protected at all costs. But security can’t get in the way of work getting done. It’s a delicate balancing act. As a leading provider of security consulting services to government and commercial customers, Kaizen Approach recognizes this. And the firm is adjusting its playbook to better manage it. Leveraging cloud-delivered digital workspace and secure access solutions from Citrix Systems, Inc. (NASDAQ:CTXS), Kaizen has created a modern security framework through which it can help itself – and its clients – deliver a simple, secure work experience that empowers employees to work when, where and how they want while keeping their information and devices safe.

Changing the Game

“Work has fundamentally changed, and security needs to change with it,” said Melissa McCoy, Chief Technology Officer, Kaizen. “Employees aren’t coming into the office every day to connect to the corporate network. Instead, they are working from anywhere. And they expect to be able to connect to the resources they need to get things done – wherever they happen to be. It is critical that companies provide this flexibility to keep them productive and engaged, but it can’t come at the expense of security.”

Moving to the Cloud

How is Kaizen delivering on this? By moving to the cloud and leveraging solutions from Citrix to secure all the tools, apps, content, and devices that employees need and prefer to use and deliver them in a simple experience that can be customized to fit their personal preferences and evolving work styles. Among the solutions Kaizen has embraced: Citrix Workspace™, Citrix ShareFile™, Citrix Secure Workspace Access™, and Citrix Analytics for Security™.

“We had a desire to put most of our IT in the cloud being a small company, and we naturally gravitated towards a company that we felt had good fundamentals when it comes to security and reliability,” McCoy said.

Simplifying the Experience

Using Citrix Workspace, Kaizen has created one digital workspace where all its important applications can be securely accessed. And leveraging Citrix Secure Workspace Access, it provides a Zero Trust architecture so that employees can securely and easily access these applications and collaborate to do their best work.

Citrix Secure Workspace Access is a VPN-less solution that delivers zero trust access and SSO to corporate web and SaaS applications for managed, unmanaged and BYO endpoints, giving end users flexibility and choice while improving the overall security.

“Our team is excited about the simplicity of their experience,” McCoy said.

Securing the Fort

And McCoy is excited about another Citrix solution, Citrix Analytics for Security, and the ability it gives her to assess, detect, and prevent risks in real time by continuously monitoring user behavior and end user device posture without hindering the user experience.

“Citrix Analytics for Security is my current favorite product, as it allows us to protect our assets in a way that is completely transparent,” said McCoy, who uses the solution to set up conditions and define actions to take based on those conditions across the cloud-based Citrix services she has in place. “When one of our employees took an international vacation and tried to access data, we had defined a policy to detect logins from outside the U.S. and block them and it worked as expected with a full audit trail that was automatically delivered.”

Citrix provides a powerful set of secure access solutions that combine a full cloud-delivered security stack integrated with identity-aware Zero Trust Network Access (ZTNA) to protect employees without getting in their way. To learn more about these solutions and the value they can deliver, click here.

About Kaizen Approach

Kaizen Approach helps government and commercial customers to strengthen their cybersecurity position and advance their workforce development. To learn more about our services, such as CMMC Preparation, visit www.kaizenapproach.com

About Citrix

Citrix (NASDAQ: CTXS) builds the secure, unified digital workspace technology that helps organizations unlock human potential and deliver a consistent workspace experience wherever work needs to get done. With Citrix, users get a seamless work experience and IT has a unified platform to secure, manage, and monitor diverse technologies in complex cloud environments.

For Citrix Investors:

This release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and of Section 21E of the Securities Exchange Act of 1934. The forward-looking statements in this release do not constitute guarantees of future performance. Those statements involve a number of factors that could cause actual results to differ materially, including risks associated with the impact of the global economy and uncertainty in the IT spending environment, revenue growth and recognition of revenue, products and services, their development and distribution, product demand and pipeline, economic and competitive factors, the Company’s key strategic relationships, acquisition and related integration risks as well as other risks detailed in the Company’s filings with the Securities and Exchange Commission. Citrix assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein. The development, release and timing of any features or functionality described for our products remains at our sole discretion and is subject to change without notice or consultation. The information provided is for informational purposes only and is not a commitment, promise or legal obligation to deliver any material, code or functionality and should not be relied upon in making purchasing decisions or incorporated into any contract.

© 2021 Citrix Systems, Inc. Citrix, the Citrix logo, and other marks appearing herein are the property of Citrix Systems, Inc. and may be registered with the U.S. Patent and Trademark Office and in other countries. All other marks are the property of their respective owners.

Karen Master

Citrix

+1 216-396-4683

[email protected]

KEYWORDS: United States North America Florida

INDUSTRY KEYWORDS: Data Management Security Technology Mobile/Wireless Software Networks

MEDIA:

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ABVC BioPharma Reports Second Quarter 2021 Results


Clinical Trials Continue Despite COVID-19 Restrictions 

Fremont, CA, Aug. 12, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — ABVC Biopharma, Inc., a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, central nervous system (CNS), and ophthalmology, today announced its unaudited financial and operating results for the three-month period ended June 30, 2021.  

  •  Revenues.We generated $31,441 and $226,513 in revenues for the three months ended June 30, 2021 and 2020, respectively; and incurred $646 and $4,236 in cost of sales for the three months ended June 30, 2021 and 2020, respectively. The decrease in revenues was mainly due to the impact of COVID-19 onto our CDMO business sector.   
  •  Operating Expenses.  Our operating expenses have increased by $650,010, or 46%, to $2,066,310 for the three months ended June 30, 2021, from $1,416,290 for the three months ended June 30, 2020. Such increase in operating expenses was mainly due to the increase in selling, general and administrative expenses and research and development expenses.

Our selling, general and administrative expenses and stock-based compensation increased by $430,224, or 34%, mainly due to the increase in company’s marketing and up-list related expenses.

Our research and development expenses increased by $219,796 or approximately 158% primarily because of new service agreements signed with vendors during the three months ended June 30, 2021.


  • Other Income (Expense). 
    Our other expense was $77,005 for the three months ended June 30, 2021, as compared to $1,038,688 for the three months ended June 30, 2020. The change was principally caused by the decrease in impairment loss of $944,204 during the quarter, and increase in interest income and rental income, as well as decreasing loss on investment in equity securities, while deducted from decrease in net other income.

Interest income was $10,722 for the three months ended June 30, 2021, as compared to $9,350 for the three months ended June 30, 2020. The increase of $1,372, or approximately 15%, was primarily due to the interest income for various related-party loans.

Loss on investment in equity securities was $53,591 for the three months ended June 30, 2021, as compared to $109,656 for the three months ended June 30, 2020. The decrease of $56,065, or approximately 51%, was primarily due to the loss on investment in BioFirst. 

Other income and government grant income totaled $162 for the three months ended June 30, 2021, as compared to $170,179 for the three months ended June 30, 2020. The decrease of $170,017, or approximately 100%, was primarily due to the tax refund for greenlight project recorded in the first half year of 2020.  


  • Net Loss.
     As a result of the above factors, our net loss was $2,052,956 for the three months ended June 30, 2021, compared to $2,184,057 for the three months ended June 30, 2020, representing a decrease of $131,101, or 6%.

“In spite of elevated COVID-19 restrictions, we were pleased to make significant clinical study progress during Q2 with respect to Vitargus, our medical device, and MDD for Cancer Patients, our depression medicine for cancer patients,” said Dr. Howard Doong, ABVC BioPharma’s chief executive officer.“For example, we identified three potential trial sites and principal investigators in Australia to conduct further clinical trials of Vitargus beginning in Q4 of this year, the data of which may be included in the pivotal trial phase required by the US FDA to obtain marketing approval. And, in connection with our medicine addressing depression for cancer patients, MDD for Cancer Patients, we submitted all necessary protocol documents to Cedar-Sinai Medical Center that we believe will enable them to issue their final approval to initiate clinical trial Phase I/II for this drug before the end of 2021.” 

Dr. Doong continued, “We also took steps during the quarter to expand our patent protection for our medicines that address MDD andAttention Deficit/Hyperactivity Disorderby applying for additional patents in both the United States and China that include the results of the Phase II human trials for these medicines.”

Subsequent to the quarter, the company completed a public offering of 1,100,000 units, consisting of 1,100,000 shares of its common stock, Series A Warrants to purchase up to 1,100,000 shares of common stock at $6.30 per share and Series B Warrants to purchase up to 1,100,000 shares of common stock at $10.00 per share, resulting in net proceeds to ABVC BioPharma of $6,021,585, after deducting the underwriting commissions and offering expenses payable by us. We intend to use the net proceeds from the offering to fund clinical trials and for working capital and general business purposes. In addition, while we have not entered into any agreements, commitments or understandings relating to any significant transaction, we may use a portion of the net proceeds to pursue acquisitions, joint ventures, and other strategic transactions.

The Company’s common stock began trading on The Nasdaq Capital Market on August 3, 2021,under the ticker symbol “ABVC”. 

About ABVC Biopharma

ABVC Biopharma is a clinical-stage biopharmaceutical company focused on utilizing its licensed technology to conduct proof-of-concept trials through Phase II of the clinical development process at world-famous research institutions (such as Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center). The company has an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development.
Disclaimer
Clinical trials are in early stages, and there is no guarantee that any specific outcome will be achieved. Past performance is not indicative of future results. Investments may be speculative and illiquid, and there is a risk of complete loss. 
Forward-Looking Statements
Clinical trials are in early stages, and there is no guarantee that any specific outcome will be achieved. This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contact:

Andy An – Chief Financial Officer
765-610-8826
[email protected]

ABVC BIOPHARMA, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

   
June 30, 
2021
    December 31,
2020
 
    (Unaudited)        
ASSETS            
Current Assets              
Cash and cash equivalents   $ 924,841     $ 4,273,208  
Restricted cash and cash equivalents     732,163       728,163  
Accounts receivable, net     297,024       159,712  
Accounts receivable – related parties, net     145,475       143,435  
Due from related parties     710,257       696,255  
Inventory, net            
Prepaid expense and other current assets     817,889       172,193  
Total Current Assets     3,627,649       6,172,966  
                 
Property and equipment, net     511,747       514,834  
Operating lease right-of-use assets     1,636,436       1,772,747  
Goodwill, net            
Long-term investments     1,095,751       1,190,727  
Deferred tax assets     1,912,356       1,790,597  
Prepaid expenses – noncurrent     119,985       119,315  
Security deposits     41,042       45,519  
Total Assets   $ 8,944,966     $ 11,606,705  
                 
LIABILITIES AND EQUITY                
Current Liabilities                
Accounts payable   $ 5,047     $ 23,044  
Short-term bank loans     1,634,500       1,629,000  
Short-term loan     100,000       100,000  
Notes payable     107,400       106,800  
Accrued expenses and other current liabilities     1,865,254       2,118,854  
Advance from customers     10,985       12,070  
Operating lease liabilities – current portion     337,170       316,178  
Due to related parties     315,676       288,445  
Convertible notes payable – related parties, current portion           250,000  
Total Current Liabilities     4,376,032       4,844,391  
Paycheck Protection Program loan payable     236,498       124,400  
Tenant security deposit     17,180       19,280  
Operating lease liability – noncurrent portion     1,299,267       1,456,567  
Convertible notes payable – noncurrent portion     2,500,000       2,500,000  
Total Liabilities     8,428,977       8,944,638  
                 
Equity                
Preferred stock, $0.001 par value, 20,000,000 authorized, nil shares issued and outstanding            
Common stock, $0.001 par value, 100,000,000 authorized, 24,470,526 and 24,420,526 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively     24,470       24,420  
Additional paid-in capital     41,001,757       40,751,807  
Stock subscription receivable     (2,708,880 )     (3,160,360 )
Accumulated deficit     (28,742,458 )     (25,642,387 )
Accumulated other comprehensive income     965,581       564,860  
Treasury stock     (9,100,000 )     (9,100,000 )
Total Stockholders’ Equity     1,440,470       3,438,340  
Noncontrolling interest     (924,481 )     (776,273 )
Total Equity     515,989       2,662,067  
                 
Total Liabilities and Equity   $ 8,944,966     $ 11,606,705  

ABVC BIOPHARMA, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
    2021     2020     2021     2020  
Revenues   $ 31,441     $ 226,513     $ 294,591     $ 305,299  
                                 
Cost of revenues     646       4,236       1,891       8,195  
                                 
Gross profit     30,795       222,277       292,700       297,104  
                                 
Operating expenses                                
Selling, general and administrative expenses     1,231,692       1,277,133       2,399,287       2,430,022  
Research and development expenses     358,878       139,082       480,193       231,872  
Stock-based compensation     475,740       75       701,480       600  
Total operating expenses     2,066,310       1,416,290       3,580,960       2,662,494  
                                 
Loss from operations     (2,035,515 )     (1,194,013 )     (3,288,260 )     (2,365,390 )
                                 
Other income (expense)                                
Interest income     10,722       9,350       63,251       20,070  
Interest expense     (82,671 )     (140,525 )     (212,900 )     (272,042 )
Rent income     53,331       5,249       58,198       10,480  
Rent income – related parties     800       1,200       2,400       2,400  
Impairment loss           (944,204 )           (944,204 )
Investment loss           (38,937 )           (38,937 )
Gain/Loss on foreign exchange changes     (5,758 )     8,656       (4,807 )     8,658  
Gain/Loss on investment in equity securities     (53,591 )     (109,656 )     (101,382 )     (180,067 )
Other income     162       170,179       233       176,501  
Government grant income                 124,400        
Total other expenses     (77,005 )     (1,038,688 )     (70,607 )     (1,217,141 )
                                 
Loss before provision income tax     (2,112,520 )     (2,232,701 )     (3,358,867 )     (3,582,531 )
                                 
Provision for income tax     (59,564 )     (48,644 )     (110,588 )     (89,212 )
                                 
Net loss     (2,052,956 )     (2,184,057 )     (3,248,279 )     (3,493,319 )
                                 
Net loss attributable to noncontrolling interests     (81,390 )     (334,760 )     (148,208 )     (396,484 )
                                 
Net loss attributed to ABVC and subsidiaries     (1,971,566 )     (1,849,297 )     (3,100,071 )     (3,096,835 )
Foreign currency translation adjustment     364,581       (10,568 )     400,721       (17,019 )
Comprehensive loss   $ (1,606,985 )   $ (1,859,865 )   $ (2,699,350 )   $ (3,113,854 )
                                 
Net loss per share:                                
Basic and diluted   $ (0.08 )   $ (0.09 )   $ (0.13 )   $ (0.16 )
                                 
Weighted average number of common shares outstanding:                                
Basic and diluted     24,421,082       19,488,168       24,420,804       19,486,355  

ABVC BIOPHARMA, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS 
FOR THE SIX MONTHS ENDED JUNE 30, 2021 AND 2020
(UNAUDITED)

    2021     2020  
Cash flows from operating activities            
Net loss   $ (3,248,279 )   $ (3,493,319 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation     5,869       21,599  
Stock based compensation for nonemployees     701,480       600  
Gain/Loss on investment in equity securities     101,382       180,067  
Government grant income     (124,400 )      
Other non-cash income and expenses           (5,886 )
Investment loss           983,141  
Deferred tax     (111,388 )     (92,062 )
Changes in operating assets and liabilities:                
Decrease (increase) in accounts receivable     (137,312 )     (39,845 )
Decrease (increase) in prepaid expenses and deposits     (219,020 )     20,091  
Decrease (increase) in due from related parties     (12,346 )     (438,174 )
Increase (decrease) in accounts payable     (17,997 )     (16,183 )
Increase (decrease) in notes payable           51,240  
Increase (decrease) in accrued expenses and other current liabilities     201,591       736,046  
Increase (decrease) in advance from others     (1,085 )     836  
Increase (decrease) in due to related parties     4,427       44,778  
Net cash used in operating activities     (2,857,078 )     (2,047,071 )
                 
Cash flows from investing activities                
Net proceeds from sale of investment           33,300  
Prepayment for equity investment     (421,974 )      
Net cash provided by (used in) investing activities     (421,974 )     33,300  
                 
Cash flows from financing activities                
Issuance of common stock for private placement           1,697,051  
Issuance of common stock for stock-based compensation           493,480  
Proceeds from short-term loan           100,000  
Proceeds from short-term borrowing from third parties           31,850  
Proceeds from short-term borrowing from related parties           71,688  
Repayment of convertible notes     (306,836 )      
Proceeds from long-term loans     236,498       124,400  
Repayment of long-term bank loans     (4,396 )     (263,362 )
Net cash provided by financing activities     (74,734 )     2,255,107  
                 
Effect of exchange rate changes on cash and cash equivalents and restricted cash     9,419       4,590  
                 
Net increase (decrease) in cash and cash equivalents and restricted cash     (3,344,367 )     245,926  
                 
Cash and cash equivalents and restricted cash                
Beginning     5,001,371       160,443  
Ending   $ 1,657,004     $ 406,369  
                 
Supplemental disclosure of cash flows                
Cash paid during the year for:                
Interest expense paid   $ 69,623     $ 59,812  
Income taxes paid   $     $  



Esports Technologies Joins the Esports Integrity Commission

Coalition Unites Betway, Entain, GGBet, and Others in Supporting the Mission to Curb and Prevent Wagering Fraud in Esports

PR Newswire

LAS VEGAS, Aug. 12, 2021 /PRNewswire/ — Esports Technologies Inc. (NASDAQ: EBET), a leading global provider of advanced esports wagering products and technology, today announced it has joined the Esports Integrity Commission (ESIC) in its mission to end match-fixing and corrupt betting activity.

Founded in 2016, ESIC is a not-for-profit association that aims to unite the esports industry under shared values and visions to fight against corruption in any form. Its members protect the integrity of esports competitions, and include tournament operators, national federations, and leaders from the esports betting and media landscape such as Betway, Entain, and GGBet.  

ESIC recently found 35 players guilty of betting-related infractions concerning official matches on the Counter-Strike matchmaking platform ESEA. The players were banned from ESIC partner competitions such as ESL, DreamHack, WePlay, BLAST, LVP, Nodwin, Eden, Relog, UCC, Allied, Kronoverse, Estars and 247 Leagues, and other events for up to 60 months.


Bart Barden, COO of Esports Technologies, said,
 “We are committed to working closely with ESIC to safeguard the integrity of esports and esports betting. As esports continues to rise in popularity, our coalition will work to build fan and bettor trust in esports tournaments. When the public has trust and confidence in the esports industry, every stakeholder wins.”


Ian Smith, ESIC Commissioner, commented,
“We are delighted to welcome Esports Technologies as an anti-corruption supporter of ESIC. Our anti-corruption supporters play an important role in our mission to deter cheating and fraudulent activity within esports betting. By joining ESIC, Esports Technologies has displayed its commitment to maintaining the integrity of esports.”

About Esports Technologies
Esports Technologies is developing groundbreaking and engaging wagering products for esports fans and bettors around the world. Esports Technologies is one of the leading global providers of esports product, platform and marketing solutions. The company operates a licensed online gambling platform, gogawi.com, that offers real money betting on esports events and professional sports from around the world in a secure environment. The company is developing esports predictive gaming technologies that allow distribution to both customers and business partners.

For more information, visit: https://esportstechnologies.com.

Forward-Looking Statements: This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which statements involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, actual results or outcomes may prove to be materially different from the expectations expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed in the Company’s filings with the Securities and Exchange Commission, including as set forth in the “Risk Factors” section of the Company’s final prospectus, which was filed with the Securities and Exchange Commission on April 16, 2021, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. The Company does not undertake any obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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SOURCE Esports Technologies Inc.